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QC Instrument and Software Validation Specialist

Job Description

ACS group has an immediate need for a 'QC Instrument and Software Validation Specialist' with experience in the Pharmaceutical Industry. This is a 6 - month contract opportunity and is located in Devens, MA. Our client is a leading Pharmaceutical company.

Please review the job description below:

Top Skills:

  • QC
  • Instrument validation
  • Laboratory
  • software validation
  • Pharmaceutical

Key Requirements and Technology Experience:

  • Participate as part of a cross functional global project to qualify QC instruments and associated software.
  • Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five QC sites.
  • Implement validation strategies for QC instrumentation and associated software, across QC Laboratories.
  • Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as;
  • Network QC Instrumentation Standardization and Windows 10 upgrades.
  • Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments.
  • Author qualification related deviations, identifying root causes and robust CAPAs.
  • Author qualification related change controls and validation plans.
  • Update procedures and documents to implement data integrity controls arising from instrument qualification programmes.
  • Serve as liaison with lab-IT teams to harmonise QC instrument's software configurations where applicable
  • Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
  • Provide updates on qualification status, project timelines, and escalate challenges as required.
  • Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team

Qualifications and Experience required:

  • Minimum of 2 years' experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role.
  • Demonstrated expertise in large projects within a complex high performance team,
  • Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
  • Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects.
  • Self-directed with a high degree of professional integrity, organization, and attention to detail.
  • Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
  • Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
  • Ability to work across timelines and be available to travel when required.
  • Demonstrated use of flexible thinking and growth mind-set is an advantage.

Candidate is expected to display the Behaviors, which enable them to be successful and perform at their highest level:

  • Passion: We pursue excellence to help patients prevail.
  • Innovation: We embrace new ideas.
  • Accountability: We own our outcomes and the outcomes of others.
  • Speed: We act with urgency and agility.

Thanks & Regards


RAHUL GULATI

Team Recruitment

P: (+1) 404-585-5612


ABOUT ACS GROUP.
- ACS Group is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies:
* AIC
*Analysts
*ComforceHealth
*HireGenics
Recent Recognitions:
#No. 6 Largest IT staffing Firm in the U.S. (2019 SIA)
#Largest Minority-Owned IT Staffing Firm in the U.S. (2018 SIA)
# No. 8 Largest IT Staffing Firm in the U.S. (2018 SIA)
#Inavero's Best of Staffing® Client Diamond Award (2018).
#National Class lV Supplier of the Year Finalist and a Regional Class IV Supplier of the Year by NMSDC
#Inavero's Best of Staffing®Client Diamond Award Winner(2017)

Website: www.acsicorp.com

Job Requirements

 

Job Snapshot

Location US-MA-Acton
Employment Type Contractor
Pay Type Year
Pay Rate N/A
Store Type Other
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Company Overview

Analysts

Analysts International Corporation (AIC) is an IT services firm fully dedicated to the success and satisfaction of its customers. From IT staffing to project-based solutions, AIC provides a broad range of services designed to help businesses and government agencies drive value, control costs and deliver on the promise of a more efficient and productive enterprise. Learn More

Contact Information

US-MA-Acton
AIC
(404)585-5612
Snapshot
Analysts
Company:
US-MA-Acton
Location:
Contractor
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

ACS group has an immediate need for a 'QC Instrument and Software Validation Specialist' with experience in the Pharmaceutical Industry. This is a 6 - month contract opportunity and is located in Devens, MA. Our client is a leading Pharmaceutical company.

Please review the job description below:

Top Skills:

  • QC
  • Instrument validation
  • Laboratory
  • software validation
  • Pharmaceutical

Key Requirements and Technology Experience:

  • Participate as part of a cross functional global project to qualify QC instruments and associated software.
  • Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five QC sites.
  • Implement validation strategies for QC instrumentation and associated software, across QC Laboratories.
  • Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as;
  • Network QC Instrumentation Standardization and Windows 10 upgrades.
  • Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments.
  • Author qualification related deviations, identifying root causes and robust CAPAs.
  • Author qualification related change controls and validation plans.
  • Update procedures and documents to implement data integrity controls arising from instrument qualification programmes.
  • Serve as liaison with lab-IT teams to harmonise QC instrument's software configurations where applicable
  • Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
  • Provide updates on qualification status, project timelines, and escalate challenges as required.
  • Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team

Qualifications and Experience required:

  • Minimum of 2 years' experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role.
  • Demonstrated expertise in large projects within a complex high performance team,
  • Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
  • Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects.
  • Self-directed with a high degree of professional integrity, organization, and attention to detail.
  • Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
  • Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
  • Ability to work across timelines and be available to travel when required.
  • Demonstrated use of flexible thinking and growth mind-set is an advantage.

Candidate is expected to display the Behaviors, which enable them to be successful and perform at their highest level:

  • Passion: We pursue excellence to help patients prevail.
  • Innovation: We embrace new ideas.
  • Accountability: We own our outcomes and the outcomes of others.
  • Speed: We act with urgency and agility.

Thanks & Regards


RAHUL GULATI

Team Recruitment

P: (+1) 404-585-5612


ABOUT ACS GROUP.
- ACS Group is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies:
* AIC
*Analysts
*ComforceHealth
*HireGenics
Recent Recognitions:
#No. 6 Largest IT staffing Firm in the U.S. (2019 SIA)
#Largest Minority-Owned IT Staffing Firm in the U.S. (2018 SIA)
# No. 8 Largest IT Staffing Firm in the U.S. (2018 SIA)
#Inavero's Best of Staffing® Client Diamond Award (2018).
#National Class lV Supplier of the Year Finalist and a Regional Class IV Supplier of the Year by NMSDC
#Inavero's Best of Staffing®Client Diamond Award Winner(2017)

Website: www.acsicorp.com

Job Requirements

 
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